CancerAPPSNCT04778878
Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device
An observational study of Cancer, run by Oulu University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to evaluate the feasibility of the Mediracer® NCS device in early detection of CIPN in patients receiving potentially neurotoxic substance (vincristine, oxaliplatin or docetaxel) as a part of their chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Mediracer® NCS
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2019to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving neurotoxic chemotherapy (oxaliplatin, vincristine, or docetaxel) as cancer treatment.
Who may be able to join
- Signed informed consent
- Planned initiation of oxaliplatin-, vincristine- or docetaxel-containing chemotherapy regimen [FOLFOX, XELOX, (R)-CHOP/CHOEP/CVOP, docetaxel, docetaxel-doxorubicin]
- Age >18y
- ECOG 0-2
- Patient compliant with the study procedures
Who cannot join
- Patient not fit/suitable for aforementioned chemotherapy regimen at baseline
- Any prior postoperative or post-traumatic conditions affecting the sensory and/or motoric peripheral nerves
- General vulnerability affecting the participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the feasibility of the Mediracer® NCS device in early detection of CIPN in patients receiving potentially neurotoxic substance (vincristine, oxaliplatin or docetaxel) as a part of their chemotherapy regimen.
- Conditions
- Cancer
- Being tested
- Mediracer® NCS
- Keywords
- CIPN, NCS
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediracer® NCSDevice
A point-of-care, hand-held nerve conduction device
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve conductivity
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Measured: 6 weeks
Nerve conductivity
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Measured: 12 weeks
Nerve conductivity
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Measured: 18 weeks
Nerve conductivity
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Measured: 24 weeks
Neuropathy related pain
Neuropathy related pain according to NPSI-assessment
Measured: 6 weeks
Neuropathy related pain
Neuropathy related pain according to NPSI-assessment
Measured: 12 weeks
Neuropathy related pain
Neuropathy related pain according to NPSI-assessment
Measured: 18 weeks
Neuropathy related pain
Neuropathy related pain according to NPSI-assessment
Measured: 24 weeks
Chemotherapy induced peripheral neuropathy (CIPN)
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Measured: 6 weeks
Chemotherapy induced peripheral neuropathy (CIPN)
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Measured: 12 weeks
Chemotherapy induced peripheral neuropathy (CIPN)
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Measured: 18 weeks
Chemotherapy induced peripheral neuropathy (CIPN)
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Measured: 24 weeks
Frequency of CIPN by CTCAE
Frequency of CIPN by CTCAE
Measured: 6 weeks
Frequency of CIPN by CTCAE
Frequency of CIPN by CTCAE
Measured: 12 weeks
Frequency of CIPN by CTCAE
Frequency of CIPN by CTCAE
Measured: 18 weeks
Frequency of CIPN by CTCAE
Frequency of CIPN by CTCAE
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Oct 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jussi Koivunen, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778878
- Sponsor's protocol ID
- 48/2019
- Acronym
- APPS
- Status last verified
- Aug 2025
- First submitted
- 23 Feb 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device
- ClinicalTrials.gov ID
- NCT04778878
- Acronym / sponsor ID
- APPS / 48/2019
- Conditions
- Cancer
- Keywords
- CIPN, NCS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility of the Mediracer® NCS device in early detection of CIPN in patients receiving potentially neurotoxic substance (vincristine, oxaliplatin or docetaxel) as a part of their chemotherapy regimen.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving neurotoxic chemotherapy (oxaliplatin, vincristine, or docetaxel) as cancer treatment.
Key inclusion criteria (5 listed)
- Signed informed consent
- Planned initiation of oxaliplatin-, vincristine- or docetaxel-containing chemotherapy regimen [FOLFOX, XELOX, (R)-CHOP/CHOEP/CVOP, docetaxel, docetaxel-doxorubicin]
- Age >18y
- ECOG 0-2
- Patient compliant with the study procedures
Key exclusion criteria (3 listed)
- Patient not fit/suitable for aforementioned chemotherapy regimen at baseline
- Any prior postoperative or post-traumatic conditions affecting the sensory and/or motoric peripheral nerves
- General vulnerability affecting the participation in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediracer® NCSA point-of-care, hand-held nerve conduction device | Device | – |
Primary outcome
Nerve conductivity
Time frame: 6 weeks
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Nerve conductivity
Time frame: 12 weeks
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Nerve conductivity
Time frame: 18 weeks
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Nerve conductivity
Time frame: 24 weeks
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Neuropathy related pain
Time frame: 6 weeks
Neuropathy related pain according to NPSI-assessment
Neuropathy related pain
Time frame: 12 weeks
Neuropathy related pain according to NPSI-assessment
Neuropathy related pain
Time frame: 18 weeks
Neuropathy related pain according to NPSI-assessment
Neuropathy related pain
Time frame: 24 weeks
Neuropathy related pain according to NPSI-assessment
Chemotherapy induced peripheral neuropathy (CIPN)
Time frame: 6 weeks
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Chemotherapy induced peripheral neuropathy (CIPN)
Time frame: 12 weeks
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Chemotherapy induced peripheral neuropathy (CIPN)
Time frame: 18 weeks
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Chemotherapy induced peripheral neuropathy (CIPN)
Time frame: 24 weeks
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Frequency of CIPN by CTCAE
Time frame: 6 weeks
Frequency of CIPN by CTCAE
Frequency of CIPN by CTCAE
Time frame: 12 weeks
Frequency of CIPN by CTCAE
Frequency of CIPN by CTCAE
Time frame: 18 weeks
Frequency of CIPN by CTCAE
Frequency of CIPN by CTCAE
Time frame: 24 weeks
Frequency of CIPN by CTCAE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conductivity (time frame: 6 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.